The law enforcement provisions of the final rule allow disclosure of protected health information without patient authorization under four circumstances: (1) pursuant to legal process or as otherwise required by law; (2) to locate or identify a suspect, fugitive, material witness, or missing person; (3) under specified conditions regarding a victim of crime; and (4) and when a covered entity believes the protected health information constitutes evidence of a crime committed on its premises. As under current law and practice, a covered entity may disclose protected health information to a law enforcement official if such official.

Based on our fact finding, we are not able to estimate any additional costs from the final rule regarding disclosures to law enforcement officials. The final rule makes clear that current court orders and grand jury subpoenas will continue to provide a basis for covered entities to disclose protected health information to law enforcement officials. The three-part test, which covered entities must use to decide whether to disclose information in response to an administrative request such as an administrative subpoena, represents a change from current practice. There will be only minimal costs to draft the standard language for such subpoenas. We are unable to estimate other costs attributable to the use of administrative subpoenas. We have not been able to discover any specific information about the costs to law enforcement of establishing the predicates for issuing the administrative subpoena, nor have we been able to estimate the number of such subpoenas that will likely be issued once the final rule is implemented.

A covered entity may disclose protected health information in response to an order in the course of a judicial or administrative proceeding if reasonable efforts have been made to give the individual, who is the subject of the protected health information, notice of and an opportunity to object to the disclosure or to secure a qualified protective order.

The Department was unable to estimate any additional costs due to compliance with the final rule's provisions regarding judicial and administrative proceedings. The provision requiring a covered entity to make efforts to notify an individual that his or her records will be used in proceedings is similar to current practice; attorneys for plaintiffs and defendants agreed that medical records are ordinarily produced after the relevant party has been notified. With regard to protective orders, we believe that standard language for such orders can be created at minimal cost. The cost of complying with such protective orders will also likely be minimal, because attorney's client files are ordinarily already treated under safeguards comparable to those contemplated under the qualified protective orders. The Department was unable to make an estimate of how many such protective orders might be created annually.

We thus do not make any estimate of the initial or ongoing costs for judicial, administrative, or law enforcement proceedings.

Survey Disclaimer

According to the Paperwork Reduction Act of 1995, no persons are required to respond to a collection of information unless it displays a valid OMB control number. The valid OMB control number for this information collection is 0990-0379. The time required to complete this information collection is estimated to average 5 minutes per response, including the time to review instructions, search existing data resources, gather the data needed, and complete and review the information collection. If you have comments concerning the accuracy of the time estimate(s) or suggestions for improving this form, please write to: U.S. Department of Health & Human Services, OS/OCIO/PRA, 200 Independence Ave., S.W., Suite 336-E, Washington D.C. 20201, Attention: PRA Reports Clearance Officer.